How is the pricing for biosimilars done

Drugs Directive: Exchange of biologics and biosimilars

Amendment to the Drugs Directive

On August 20, 2020, the Federal Joint Committee decided to change the Drugs Directive. Doctors must then prescribe biologics in the sense of an “economic prescription”. The aim of this change is to increase the proportion of cheaper biosimilars in the prescription of biologics in order to save costs.

Economic regulation

This way of prescribing is already a reality when it comes to prescribing conventional medicines. For example, if the doctor wants to prescribe acetylsalicylic acid (aspirin), patients may not be prescribed the original, but a cheaper drug from another manufacturer with the identical active ingredient (generic).

The innovation in the Drugs Directive is that this type of regulation now also applies to biologics, specifically for the change from the expensive original biologics to the inexpensive biosimilars. This change in the Drugs Directive was necessary because biosimilars - in contrast to generics - are not identical to the original biological, but only similar, even though they have the same active ingredient name.

How will the change affect people with rheumatism?

If people with rheumatic diseases go to their rheumatologist in the future to get a new prescription, the doctor must check whether the previous drug is actually inexpensive. First and foremost, the doctor must compare whether biologics with the same active ingredient name (e.g. adalimumab or etanercept) are on the market in Germany.

What happens in which situation:

Case 1: There is no other biological agent with the same active ingredient name. In this case, nothing changes, the person concerned continues to receive his or her previous drug.

Case 2: There are several biologics with the same active ingredient name, i.e. an original biologic and at least one biosimilar. The doctor must check whether the health insurance of the person concerned has a discount agreement for the previous drug. If this is the case, nothing changes - the person concerned continues to receive the previous drug.

Case 3: There are several biologics with the same active ingredient name, but the health insurance of the person concerned has not concluded a discount agreement with the manufacturer of the previous drug. The doctor has to find a drug with the same active ingredient name, for which there is a discount agreement between the health insurance company and the manufacturer. In practice, this presumably means above all that those affected will in future be prescribed a biosimilar with the same active ingredient name instead of the original biologic. But even if a person concerned already receives a biosimilar for which there is no discount agreement, they must be switched to another biosimilar with the same active ingredient name (or even to the original biological) if a discount agreement should exist for this in turn. If there are no discount agreements for the original biologic and its biosimilars, the doctor has to find out by other means which medicinal product is inexpensive.

How long does the exchange last?

As long as the discount agreements are running, no further changes need to be made. The discount contracts should usually run for two years, but can then also be extended. In this respect, it is possible that the amendment to the Drugs Directive will not have any effect on the individual affected, even for years. In special cases, however, it can also happen that a person concerned is newly hired for a biological product whose discount agreement is about to expire. In this case, the person affected would have to be converted again after less than two years.

What exceptions will there be?

The Federal Joint Committee has emphasized that the doctor can refrain from changing therapy after considering patient-specific and disease-specific aspects. This can be effective, for example, if the patient is not yet stable on a drug. However, side effects that have already occurred during previous treatment with the inexpensive drug can of course be a reason why the doctor can refrain from changing therapy.

How secure is the exchange?

Biosimilars are an effective and safe alternative to the original biologics in the treatment of rheumatic diseases. This has been shown in numerous high quality studies. The German Rheuma League sees the place of biosimilars primarily in the recruitment of new patients. However, a one-time change of therapy from an original biologic to a significantly cheaper biosimilar can also be considered after consultation with the person concerned in order to conserve the resources of the health system.

Various studies have shown that a one-time change from an original biological to a biosimilar is harmless.

Which active ingredients are exchanged?

Currently (as of November 10, 2020) the amendment to the Drugs Directive is only relevant for the active ingredients adalimumab, etanercept, infliximab, rituximab and teriparatide. In Germany, biosimilars are currently only approved for these active ingredients in the field of rheumatology. Those affected who are treated with other biologics or Janus kinase inhibitors are currently not affected by the change in the drug directive and thus by such changes in therapy for cost reasons (as of November 10, 2020).

The website of the German Rheuma League provides an overview of the original biologics approved in Germany and any biosimilars.

What does the Rheumatism League say about these changes?

In the Federal Joint Committee, the German Rheuma League, together with other patient organizations, has taken a stand against the change in the Drugs Directive. Above all, we criticize the possibility that those affected may have to switch from one biosimilar (or the original biologic) to another biosimilar (or the original biologic) or back again several times for cost reasons alone. (Complete statement from the German Rheumatism League)

What has the German Rheuma League achieved?

The German Rheumatism League, together with the other patient organizations, ensured that the decision of the Federal Joint Committee stipulated that the doctor should inform the person affected about the reasons for the changeover. The doctor or healthcare professional should also demonstrate how to use the new drug. With this measure, the German Rheuma League hopes that there will be fewer application errors and that it will be easier for those affected to accept the new preparation. The fact that the doctor can refrain from changing therapy while considering patient-specific and disease-specific aspects can also be traced back to the efforts of the German Rheumatism League and other patient organizations. In addition, the patient representatives have ensured that in future the doctor will have an official list of which drugs should be exchanged for one another.

When does the change take effect?

The decision was examined by the Federal Ministry of Health in November and published in the Federal Gazette. It is therefore already in force.

How will it go on?

The amendment to the Drugs Directive is part of a law with the aim that, from 2022, it is not the doctor but the pharmacist who selects the inexpensive biological agent (original biological agent or biosimilar) (automatic substitution). In further negotiations in the Federal Joint Committee, the German Rheuma League will advocate patient interests and oppose this automatic substitution.

Author: Dr. Jürgen Clausen is research officer for the German Rheuma League.

Medicines for rheumatism

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